Pfizer Canada ULC is recalling all lots of Accuretic (quinapril hydrochloride and hydrochlorothiazide) medication in 10/12.5 mg, 20/12.5 mg and 20/25 mg strengths due to the presence of a nitrosamine impurity (N-nitroso-quinapril) above the acceptable level.

Accuretic is a prescription drug used to treat high blood pressure. It contains a combination of quinapril hydrochloride and hydrochlorothiazide, which both lower blood pressure.

Long-term exposure to N-nitroso-quinapril at a level above what is considered acceptable may increase the risk of cancer. We are all exposed to low levels of nitrosamines through a variety of foods (such as smoked and cured meats, dairy products and vegetables), drinking water and air pollution. This impurity is not expected to cause harm when ingested at or below the acceptable level. A person taking a drug that contains this impurity at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer.

As with previous recalls involving nitrosamine impurities, Health Canada is advising that there is no immediate risk in continuing to temporarily take the recalled Accuretic medication since the potential risk of cancer is with long-term exposure (every day for 70 years) to the nitrosamine impurity above the acceptable level. Patients can continue to take their medication as prescribed by their health care provider and do not need to return their medication to their pharmacy, but they should contact their health care provider to discuss other treatment options.

Health Canada is monitoring the effectiveness of the recall and the company’s implementation of any necessary corrective and preventative actions. Should any additional recalls be deemed necessary, Health Canada will update the table and inform Canadians.